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902575

The Children's Hospital Corporation — FEI 1274061

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 26, 2014
Fiscal Year
2014
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Boston, MA (United States)

Facility

Other inspections at this facility

  • 1229896 (NAI Wed Jul 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100251 (NAI Fri Aug 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002810 (VAI Tue Feb 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 673463 (NAI Wed Jul 28 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
7821 CFR 606.100(c)Record review prior to release
908921 CFR 600.14(c)When to report